Evaluation and Neural Basis of Communication in Patients With Multiple Sclerosis

NCT ID: NCT02652013

Last Updated: 2020-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2020-01-31

Brief Summary

Multiple sclerosis (MS) progressively leads to an increasing level of disability. That's why individuals faced with this chronic disease whose progression is unpredictable have to mobilize all their available resources. As a result, management of interpersonal relationships appears to be a key issue in adjustment to situations.

Although knowledge on cognitive abnormalities in MS has been growing in recent years, there is a lack of research about social behaviour regulation skills. The few studies conducted in this field are mainly interested in emotional processing (emotional facial recognition and empathy) and skills mentalizing (theory of mind) that appear disturbed in MS.

While some recent studies touch on the issue of the contextual analysis of language (that is to say, the social use of language) in MS, their assessment on a wide range of pragamtic skills has never been studied. However, the pragmatic aspects of language are known to play a major role in social adjustment.

This project has three main objectives : (1) to increase general knowledge of deficits in communication and in social cognition in patients with MS, (2) to propose new leads for the evaluation of these disorders and (3) to contribute to increasing knowledge of neural basis of communication and social cognition.

In order to address those objectives, the assessment will be focused on many various pragmatics skills : conversation, indirect language comprehension (indirect questions, idiomatic expressions, sarcasm) and metapragmatic knowledge in a population of 40 RR-MS patients. Those patients' performances will be compared to a group of healthy matched control subjects, potential relationships between pragmatic abilities, other aspects of social cognition (theory of mind and processing of emotional stimuli), cognitive functioning, psycho-behavioural aspects and the characteristics of the disease will be explore.

Social cognition tasks have been selected for their dynamic and ecologic aspects in order to match natural social interaction.

Finally, communication consideration, cognitive and cerebral skills of patients with MS will contribute to increasing knowledge of the neural basis of social cognition.

Conditions

Multiple Sclerosis; Social Cognition; Neuropsychology; Psychological Therory; Theory of Mind

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

40 patients with multiple sclerosis

The study sample will consist of 40 patients with multiple sclerosis. MS patients and control subjects will be recruited on the Rennes (Centre Hospitalier Universitaire and Pôle de Médecine Physique et de Réadaptation Saint-Hélier) and Angers sites (Centre Hospitalier Universitaire) participating in COGNISEP project

Group Type: EXPERIMENTAL

cognitive evaluation

Intervention Type: OTHER

40 healthy subjects

All the performance of the 40 MS patients will be compared to 40 control subjects matched in age, gender and sociocultural level. Subjects with a history of neurological and psychiatric condition or substance abuse will be excluded from the study. Control subjects will receive an honorary as a token for their time.

Group Type: OTHER

cognitive evaluation

Intervention Type: OTHER

Interventions

cognitive evaluation

Intervention Type: OTHER

Eligibility Criteria

Exclusion Criteria

• Relapsing-remitting form as defined by the Mc Donald's Committee criteria (2005).
• EDSS between 0 and 5.5, out of relapses
• French mother tongue or having been schooled in France
• No disorders of formal language comprehension
• Not having participated to a similar protocol within the 9 months preceding the inclusion

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rennes University Hospital

OTHER

Sponsor Role: collaborator

University Hospital, Angers

OTHER_GOV

Sponsor Role: collaborator

Université Européenne de Bretagne

OTHER

Sponsor Role: collaborator

Pôle Saint Hélier

OTHER

Sponsor Role: lead

Responsible Party

Philippe Gallien

Medical Doctor HDR

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Philippe Gallien, doctor

Role: PRINCIPAL_INVESTIGATOR

Pôle Saint Hélier

Locations

Pôle Saint Hélier

Rennes, Brittany Region, France

Countries

France

Other Identifiers

2015-A00624-45

Identifier Type: -

Identifier Source: org_study_id